Kornimate/medical-research-clean huggingface dataset:
effect of low calorie diet with rice bran oil on cardiovascular risk factors in hyperlipidemic patients

Conditions: Hyperlipidemias

Summary: the purpose of this study is to determine the effect of rice bran oil with low calorie diet on lipid profiles.

this study is parallel groups' randomized clinical trial with a pre and post test design. the study conducted on hyperglycemia patients who were healthy in other respects and were recruited from nutrition and diet therapy clinic. all subjects received a low calorie diet for 4 weeks from registered dietitian. treatment group received the low- calorie diet including (30g/day) rice bran oil.

Eligibility criteria:
inclusion criteria: * hyperlipidemia exclusion criteria: * pregnancy and lactation * cardiovascular disease * diabetes

Keywords: rice bran oil diet cardiovascular disease low density lipoprotein total cholesterol
mediators of atherosclerosis in south asians living in america (masala) social network study

Conditions: Atherosclerosis

Summary: it has been argued that social relationships are important to health and well-being. this study will investigate links between social networks and cardiovascular disease risk factors in south asians, the second fastest growing ethnic group in the us and one with disparate rates of coronary heart disease. identifying and understanding the links between social networks and cardiovascular disease is key to the development and testing of family- and community-level prevention interventions for minorities.

this study will use mixed-methods to investigate links between social networks and cardiovascular disease risk factors in south asians, the second fastest growing ethnic group in the us and one with disparate rates of coronary heart disease. identifying and understanding the links between social networks and cardiovascular disease is key to the development and testing of family- and community-level prevention interventions for minorities.

Eligibility criteria:
inclusion criteria: participants enrolled in the mediators of atherosclerosis in south asians living in america (masala) study. exclusion criteria: people not enrolled in the mediators of atherosclerosis in south asians living in america (masala) study.

Keywords: cardiovascular disease social network south asians
l-prf vs pbm on extraction socket healing

Conditions: Healing Surgical Wounds; Pain

Summary: the aim of this study is to compare leukocyte and platelet-rich fibrin (l-prf) and photobiomodulation (pbm) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets.

after sample size calculation, healthy volunteers were included in the study. both teeth of these individuals with bilaterally impacted wisdom teeth were extracted simultaneously. photobiomodulation (pbm) or leukocyte and platelet rich fibrin (l-prf), an autogenous blood product, was randomly applied to the right or left side extraction sockets. volunteers were called for repeat sessions (days 2,4,7,7,11,11,14,18 and 21) for the pbm treated side. follow-ups were performed for pain (days 2,4,7) and soft and bone tissue healing.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) class-i healthy volunteers * between 18 and 40 years of age who had wisdom teeth (pell and gregory class ii, position b) with bone retention in bilateral symmetrical position with an indication for extraction, and had second molars in the mouth, * not use steroids or anti-inflammatory drugs in the last 3 months. exclusion criteria: * patients with pericoronitis, * smoking habits * active periodontal disease * pregnancy, * breastfeeding * unable to give personal consent, and those with missing physical examination and follow-up records were excluded.

Keywords: photobiomodulation l-prf pain bone healing soft tissue healing third molar
the early nasojejunal tube to meet energy requirements in intensive care (enteric) study

Conditions: Critical Illness; Malabsorption Syndromes

Summary: this is a multi-centre randomised controlled trial comparing early jejunal feeding (using a frictional nasojejunal \[nj\] tube) and standard feeding in critical illness.


Eligibility criteria:
inclusion criteria: icu patients are eligible for enrolment if they meet all of the following: * age \> 18 years old * in icu for \< 48 hours prior to enrolment * receiving invasive mechanical ventilation (through an endotracheal tube or tracheostomy, but not a facemask) with an anticipated need for \> 48 hours of mechanical ventilation * receiving a continuous infusion of any one of: * morphine \> 2 mg/hour, * fentanyl \> 20 mcg/hour, or * pethidine \> 20 mg/hour * either a single grv \> 150 mls (whilst receiving en via a ng tube) or nasogastric drainage \> 500 mls over 12 hours (whether receiving en or not) exclusion criteria: patients will be ineligible for enrolment if they meet any of the following: * previous or recent surgery which has altered the anatomy of the upper gastrointestinal tract (eg. oesophagectomy, gastrectomy, any gastric anastomosis surgery, gastroplasty, pyloroplasty, pancreaticoduodenectomy \[whipple's procedure\]) * known gastric malignancy * known oesophageal varices * current admission for peptic ulceration * current mechanical bowel obstruction * current gastrostomy, jejunostomy, or surgically-placed enteral tube in situ * contraindication to the use of the nose and mouth for enteral tube insertion (eg. recent facial trauma or surgery) * receiving nutritional support prior to icu admission * severe coagulopathy (defined by platelet count \ 4.0)

Keywords: mechanically-ventilated medical-surgical critically ill patients reduced gastric motility
reducing disparities in rural hiv prevention

Conditions: HIV Infections; Sexually Transmitted Infections

Summary: hiv and sexually transmitted infection (sti) rates are increasing in rural areas including rural colorado. many rural residents find it difficult to access hiv and sti prevention services. in this study, an online survey on hiv and sti prevention and best practices to provide access to prevention will be administered to rural residents in three zip 3 zones in rural colorado. in addition to the baseline survey, study participants who are interested and medically eligible may initiate prep services with the university of colorado hiv prevention program and receive prep through telemedicine visits, mailed home lab kits, and mailed medication. persistence in prep care, acceptability, and feasibility of telemedicine and home lab kits will be measured.

hiv and sexually transmitted infection (sti) rates are increasing in rural areas including rural colorado. many rural residents find it difficult to access hiv and sti prevention services. the goal of this study is to understand the risk for hiv and stis, views on prep, and to determine if access to telemedicine visits and home lab kits increases engagement in prep services and persistence in care for at-risk rural populations. an online survey on hiv and sti prevention and best practices to provide access to prevention will be administered to rural residents in three zip 3 zones in rural colorado, comprised of increased proportions of minority residents (hispanic, native american, and black). in addition to the baseline survey, study participants who are interested and medically eligible may initiate prep services with the university of colorado hiv prevention program and receive prep through telemedicine visits, mailed home lab kits, and mailed medication. persistence in prep care, acceptability, and feasibility of telemedicine and home lab kits will be measured through baseline and follow-up survey questionnaires and clinical chart reviews for those engaged in prep care.

Eligibility criteria:
inclusion criteria: 1. colorado rural or frontier county residents, adults (age 18+) 2. access to internet, smart phone or tablet to participate in online surveys 3. able to complete online surveys in english or spanish exclusion criteria: 1. residence in an urban colorado county 2. hiv positive status 3. no internet, smart phone, or tablet access 4. unable to complete online surveys in english or spanish

Keywords: hiv prevention, access, rural communities
neuropathy evaluation using the vibration of a mobile phone

Conditions: Diabetic Foot

Summary: a single centre validation/method comparison study of the experimental nerve device for the measurement of vibration perception threshold against the established 'neurothesiometer' device, evaluating agreement and reliability. it will also include collecting feedback from patients, carers and clinicians on the usability of the device


Eligibility criteria:
inclusion criteria: * formally diagnosed with diabetes exclusion criteria: * 1. un- willing or un-able to provide free informed consent (no time limit) * 2. un-willing or un-able to comply with all protocol requirements including study assessments; * 3. bilateral foot ulcers
eating disorders genetics initiative 2

Conditions: Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Avoidant Restrictive Food Intake Disorder

Summary: the overarching intention of the eating disorder genetics initiative 2 (edgi2) is to increase sample size, diversity, and eating disorder phenotypes. the investigators are enrolling 20,000 new participants with anorexia nervosa (an), bulimia nervosa (bn), binge-eating disorder (bed), avoidant/restrictive food intake disorder (arfid), and controls in the us, mexico, australia, new zealand, sweden, and denmark. a primary study goal is to enroll at least 30% of participants from underrepresented groups. participants are asked to complete a series of questionnaires and submit a saliva sample for genotyping. the goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.


Eligibility criteria:
inclusion criteria: * a lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, avoidant restrictive food intake disorders or no history of any disordered eating behavior, based on dsm-5 criteria algorithms * age 12-99 years, depending on country. (us enrollment age is 18-99) exclusion criteria: * history of subthreshold disordered eating behaviors.

Keywords: severe and enduring eating disorder genetics mental health disordered eating environmental factors
assessment of safety and efficacy of thiscart19a in adult patients with b cell malignancies after failure of autologous chimeric antigen receptor t- cell(car-t) therapy

Conditions: Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited

Summary: this is a a phase 1, open label study to assess the safety and efficacy of thiscart19 (allogeneic car-t targeting cd19) in adult patients with b cell malignancies after failure of autologous chimeric antigen receptor t- cell(car-t) therapy in china.

this is a phase 1, single-center, nonrandomized, open-label, dose-escalation and dose expansion study to evaluate the safety and efficacy of thiscart19a in adult patients with b cell malignancies after failure of autologous chimeric antigen receptor t- cell(car-t) therapy and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile.

Eligibility criteria:
inclusion criteria: 1. patient with relapsed or refractory acute lymphocytic leukemia, or lymphoma； 2. no gender limitation, age 14 years to 75 years (both upper and lower limits included)； 3. failing to autologous car-t therapy； 4. should be confirmed cluster of differentiation(cd)19 positive； 5. the expected survival time is ≥12 weeks; 6. ecog score 0-1; 7. measurable or detectble disease at time of enrollment. 8. adequate bone marrow, renal, hepatic, pulmonary and cardiac function； exclusion criteria: 1. allergic to preconditioning measures； 2. patients with other malignancies other than b-cell malignancies within 5 years prior to screening. patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited； 3. uncontrollable bacterial, fungal and viral infection during screening； 4. patients had pulmonary embolism (pe) and/or deep vein thrombosis (dvt) within 3 months prior to enrollment; 5. had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment； 6. the presence of central nervous system involvement； 7. active hepatitis b virus (hbv) or hepatitis c virus (hcv) or human immunodeficiency virus (hiv) or syphilis infection. hbv-dna \< 2000 iu/ml can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment； 8. had big lesion(single lesion diameter ≥10 cm)； 9. receive allogeneic hematopoietic stem cell transplantation less than 100 days； 10. vaccinated with influenza vaccine within 2 weeks prior to cleansing (sars-cov19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included)； 11. patients who are receiving gvhd treatment; patients without gvhd and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion； 12. women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. male subjects who plan pregnancy within 1 year after infusion.
biofreedom qca study in cad patients

Conditions: Coronary Artery Disease; Cardiac Death; Myocardial Infarction

Summary: this study aims to demonstrate that the biofreedom™ cobalt chromium drug coated stent is non-inferior to the market authorized biofreedom™ stainless steel stent with respective to efficacy and shows a similar safety profile.

the biofreedom™ qca trial is designed to evaluate the safety and efficacy of the biofreedom™ cocr dcs coronary stent system compared to the biofreedom™ stainless steel dcs coronary stent system, in a randomized controlled trial on an all-comers patient population. the primary objective is to measure non-inferiority of the biofreedom™ cocr stent compared to biofreedom™ dcs as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary endpoint is to assess safety as measured by mace and st. two hundred (200) patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed-up to 2 years to measure for late mace and st events.

Eligibility criteria:
inclusion criteria: "real world, all comer" patients 1. age ≥18 years; 2. symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-st elevation myocardial infarction and st-elevation myocardial infarction; 3. presence of one or more coronary artery stenosis \>50% in a native coronary artery or a saphenous bypass graft from 2.50 to 3.5 mm in diameter that can be covered with one or multiple stents (angiographic inclusion); 4. no limitation on the number of treated lesions, and vessels, and lesion length exclusion criteria: 1. individual is pregnant, nursing or planning to be pregnant; 2. known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, biolimus a9™ or contrast material 3. inability to provide informed consent; note: not all exclusion criteria are listed.
nintedanib plus egfr tki in egfr-mutated non-small cell lung cancer patients

Conditions: Non-small Cell Lung Cancer; EGFR Gene Mutation; EGFR-TKI Resistant Mutation

Summary: the purpose of this study is to evaluate the efficacy and safety of nintedanib with egfr-tki in participants with advanced egfr-tki-resistant non-small cell lung cancer

the efficacy of the regimen is evaluated by participants' progression-free survival and overall survival. nintedanib is a medication that blocks endothelial cells in tumor microenvironments and is effective in delaying tumor progression. nintedanib is also a drug approved for idiopathic pulmonary fibrosis in the clinic. the participants will take 1 nintedanib tablet after a meal twice per day with a twelve-hour interval. egfr tki-gefitinib, erlotinib, afatinib, or osimertinib will be taken 1 tablet once per day during each treatment cycle. the treatment cycle in this study is 30 days. in this study, the participants will have a physical exam in 6 weeks and 12 weeks after the initiation of the treatment. in the 6 weeks of the study, the participants will have blood tests and a ct scan. about 5cc of blood will be collected each time. in addition, the participant's tumor will be measured by a ct scan every 12 weeks. if the participants develop any unacceptable symptoms or changes in liver function tests, the participants' treatment may be delayed and/or the dose decreased until the symptoms are disappeared. it may even be necessary to stop your treatment. the doctor will inform the participant of any changes in the participants' treatment schedule or in the doses of medication after he/she evaluates the participants in the clinic. after treatment ends, the participants will have a follow-up visit at the clinic. at this visit, the participants will have a complete physical exam, including blood (about 5cc) tests and ct scan to measure the size of the tumors. this is an investigational study. up to 20 participants will take part in this study.

Eligibility criteria:
inclusion criteria: 1. participants between 20 to 70 years old, are pathologically confirmed advanced (stage iii and iv) non-small cell lung cancer. 2. positive egfr mutations are diagenesis. 3. participants with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype nsclc after the failure of first-line egfr tyrosine kinase inhibitors- gefitinib, erlotinib, afatinib, or osimertinib. 4. participants must have adequate hepatic, renal, and bone marrow function exclusion criteria: 1. participants previously received first-line egfr tyrosine kinase inhibitor with serious side effects. 2. participants have known hypertension, and chronic liver and gastrointestinal disease. 3. participants have known brain metastasis. 4. female participants who are pregnant or breast-feeding 5. participants have a known diagnosis of negative npkcδ expression by immunohistochemistry (ihc).

Keywords: npkc delta angiogenesis egfr tki drug resistant
pretreatment group consultation for patients with colorectal cancer

Conditions: Colorectal Neoplasm

Summary: an explorative study of the patients' experience of participating at a group consultation, together with other patients with newly diagnosed colon or rectal cancer

the group consultation is planned to be on the friday of the same week as the patient recieved a suggested treatment plan i.e. after mdt, at a personal consultation with his/her colorectal surgeon. during the group consultation the steps necessary for the patient to take responsability for in connection with the operation. ample time for questions, clarifications and discussions. appropriate clinical trials are presented

Eligibility criteria:
inclusion criteria: * patients participating in the pretreatment group consultation exclusion criteria: * not able to answer questionnaire
incidence of antibiotic resistant e.coli in patients undergoing repeat prostate biopsy

Conditions: Bacterial Infection

Summary: the purpose of this study is to discover how often certain bacteria are found in the rectum at the time of a prostate needle biopsy to diagnose prostate cancer. certain bacteria are of importance because they can cause serious infection. antibiotics that urologists commonly use to prevent these bacteria from causing infection are no longer effective. many physicians around the world are noting increased infections with antibiotic resistant bacteria. therefore; despite treating patients who are to undergo prostate biopsy with antibiotics, certain patients are being readmitted to the hospital with a serious infection. in order to study the incidence of these particular bacteria, the best method is to culture the bacteria at the time of the biopsy. this involves one rectal culture swab just prior to needle biopsy of the prostate. once the incidence of these bacteria is known we may take steps to prevent the serious infections that occur as a result of prostate biopsy.


Eligibility criteria:
inclusion criteria: * adult males * repeat prostate biopsy exclusion criteria: * first time prostate biopsy * minors

Keywords: e. coli prostate biopsy
intraoperative electrically-evoked abrs in patients undergoing vestibular schwannoma surgery

Conditions: Deafness

Summary: this is a study of the feasibility of activating the auditory system by an electrode in direct contact with the cochlear nerve.

this is a feasibility study being conducted prior to development of a penetrating cochlear nerve stimulating electrode. experiments will be conducted in patients who are undergoing surgery for resection of a vestibular schwannoma (vs). in the normal course of such a surgical procedure, the cochlear nerve is exposed and, in many cases, the cochlear nerve is resected or function of the cochlear nerve is otherwise disrupted. typically, recording electrodes are placed on the scalp for the purpose of recording sound-evoked auditory brainstem responses (abrs), which serve as a measure of the functional status of the cochlear nerve. in this intraoperative experimental procedure, a conventional bipolar nerve stimulating electrode will be placed in contact with the cochlear nerve and the nerve will be stimulated with electrical pulses. activation of the auditory system by the electrical pulses will be evaluated by measurement of electrically-evoked abrs, using the same scalp electrodes that are typically used for measurement of sound-evoked abrs. the cochlear-nerve stimulating electrode will be in place only during the actual intraoperative test. no device will remain in the patient. the intraoperative experimental procedure is not intended to as a therapeutic measure for the patient's vs.

Eligibility criteria:
inclusion criteria: * adults with the diagnosis of unilateral or bilateral vestibular schwannoma proven on radiographic imaging. * only patients with little or no hearing ability undergoing surgical resection of the tumor will be enrolled. exclusion criteria: * women who are pregnant

Keywords: vestibular schwannoma cochlear nerve auditory prosthesis